A Study of Lebrikizumab in Patients with Persistent Moderate to Severe Atopic Dermatitis

Phase 1

Conditions: Atopic Dermatitis
MedDRA version: 17.1Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2014-000049-56-CZ

Lead Sponsor: F. Hoffmann-la roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

- Age 18 to 75 years, inclusive, at the start of the run-in period
- AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1 year at screening
- Moderate to severe AD as graded by the Rajka/Langeland criteria at screening
- History of inadequate response to a >/= 1 month (within the 3 months prior to the screening visit) treatment regimen of at least daily TCS and regular emollient for treatment of AD
- EASI score >/= 14 at screening
- IGA score >/= 3
- AD involvement of >/= 10% body surface area
- Pruritus Visual Analog Scale score >/= 3

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 198
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

- Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
- Use of an investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer
- Evidence of other skin conditions, including, but not limited to, T-cell lymphoma or allergic contact dermatitis
- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- Use of any complementary, alternative, or homeopathic medicines including, but not limited to, phytotherapies, traditional or non-traditional herbal medications, essential fatty acids, or acupuncture within 7 days prior to the run-in period or need for such medications during the study
- Evidence of other skin conditions; including, but not limited to, T-cell lymphoma or allergic contact dermatitis
- Evidence of, or ongoing treatment (including topical antibiotics) for active skin infection at screening
- Other recent infections meeting protocol criteria
- Active tuberculosis requiring treatment within the 12 months prior to Visit 1
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- Known immunodeficiency, including HIV infection
- Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the patient is willing to stop TCI use during the study (including the run-in period) and, in the investigators opinion, it is safe to do so
- Clinically significant abnormality on screening ECG or laboratory tests
- Known current malignancy or current evaluation for a potential malignancy, including basal or squamous cell carcinoma of the skin or carcinoma in situ
- History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the efficacy and safety of lebrikizumab used as adjunctive therapy with topical corticosteroid (TCS) compared with TCS alone in patients with persistent moderate to severe atopic dermatitis.;Secondary Objective: To evaluate the efficacy of lebrikizumab adjunctive therapy with TCS compared with TCS alone, as measured by AD symptoms, including pruritis, and AD-specific health-related quality of life.<br>• To evaluate the pharmacokinetics and immunogenicity of lebrikizumab administered by subcutaneous (SC) injection<br>• To evaluate AD-related biomarkers and the effect on their expression from lebrikizumab used as adjunctive therapy with TCS compared with TCS ;Primary end point(s): Percentage of patients achieving a 50% reduction in Eczema Area and Severity Index (EASI) score (EASI-50) from baseline to Week 12<br><br>;Timepoint(s) of evaluation of this end point: From Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Outcome Measure: Efficacy (composite outcome measure): Percent and absolute change from baseline in EASI score at Week 12<br>2. Outcome Measure: Percent of patients achieving an Investigators Global Assessment (IGA) score of 0 or 1 at Week 12<br>3. Outcome Measure: Efficacy (composite outcome measure): Percent and absolute change from baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12<br>4. Outcome Measure: Frequency and severity of treatment-emergent adverse events;Timepoint(s) of evaluation of this end point: 1 to 3. From Baseline to Week 12<br>4. Up to Week 20

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